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Pharm Analysis 2 > Quiz #1 > Flashcards

Quiz #1 Flashcards

1
Q

Totality of characteristics or features of a product that bears on its capacity to satisfy stated or implied needs

A

Quality

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2
Q

CGMP meaning

A

Current Good Manufacturing Practice

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3
Q

CGMP was promulgated by the US FDA in _____ and finalized on ______.

A

1963 & 1979

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4
Q

CGMP was established _______

A

To ensure that minimum standards are met for a drug product quality

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5
Q

Sum total of organized arrangement and has objective in assuring quality required by their intended use.

A

Quality assurance

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6
Q

Helps to identify and prepare necessary SOP’s relative control quality.

A

Quality Assurance Department Functions

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7
Q

SOP meaning

A

Standard Operation Procedures

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8
Q

Determine if operations have adequate systems, facilities and written procedures

A

Audit and Quality Monitoring

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9
Q

Assures policies are followed inept to economic issues associated with manufacturing and distribution of product.

A

Audit and Quality Monitoring

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10
Q

Cooperate with regulatory agencies and final authority for product acceptance or rejection.

A

Audit and Quality Monitoring

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11
Q

This is a part of CGMP concerned with sampling, specifications, testing, organization, documentation, and release until quality is judged satisfactory.

A

Quality control

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12
Q

3 functions of quality control (TIM)

A
  1. Testing and acceptance of any high quality raw materials.
  2. IP tests against criteria
  3. Monitors environmental conditions
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13
Q

RMQC

A

Raw Material Quality Control

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14
Q

IPQC

A

In Process Quality Control

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15
Q

FPQC

A

Future Product Quality Control

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16
Q

Document that specifies all the tests TO BE CONDUCTED on a product.

A

Monograph

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17
Q

Document with the results of all TESTS CONDUCTED on material to show compliance or noncompliance.

A

Certificate Analysis

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18
Q

This is generated to explain in detail the behind a procedure and proper sequence of STEP TO BE DONE.

A

SOP/ Standard Operation Procedure

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19
Q

SOP includes:

A

Record Keeping
Facilitate recall
Step by step method

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20
Q

It is finite number of objects selected from batch of a product or from a population.

A

Sample

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21
Q

This is take from a population and represent the whole batch from where it is taken.

A

Sample

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22
Q

What is Accuracy or Accurate?

A

Closeness of test results to the true value.
Example: result is 3.5 but the answer is 3.3

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23
Q

Degree of agreement among individual test results when the method is applied repeatedly to multiple samplings of a homogenous sample.

A

Precision

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24
Q

It involves Class 1-4

A

Analytical Balances

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25
It is a class of A.B where they recommended for balances using optical or electrical methods for accurately weighing quantities below 20 mg.
Class 1.1
26
Class of A.B with high precision standard for calibration, used for weighing accurately quantities below 20 mg.
Class 1
27
Class of A.B where used for qty greater than 20 mg
Class 2
28
It is classes of A.B where they used with moderate precision laboratory chances.
Class 3 & 4
29
Class of A.B where used for qty greater than 50 mg
Class 3
30
Class of A.B where used for qty greater than 100 mg
Class 4
31
What are the 3 kinds of defects?
MINOR MAJOR CRITICAL
32
It is kind of defects where it makes the product dangerous or not viable for its intended use
Critical Defect
33
It is kind of defect where they may effect the function of an object and therefore, may render the product useless.
Major Defect
34
Kind of defect where it's not likely to reduce materially the viability of the product of its intended purpose but represents a departure from established std having little bearing on the effective use of the product.
Minor Defect
35
RMQC includes these tests:
ID tests Purity tests Limit tests Physical tests
36
Debasement f article and involves contamination
Adulteration
37
What are the 5 classification of Adulteration.
Sophistication Spoilage Substitution Admixture Deterioration
38
True adulteration and addition of inferior material to any article
Sophistication
39
Example of Sophistication
Teatree oil-- olive oil and Safflower---saffron
40
Entirely different is used in place of the requested and almost the same with sophistication
Substitution
41
Example of Substitution
Japanese anise- Star anise
42
Addition of an article to another through accident, ignorance and carelessness
Admixture
43
Quality if destroyed by action of microorganism
Spoilage
44
Example of Spoilage
Sarsapilla with soil
45
Quality impaired by abstraction, destruction of valuable due to environmental agents, insects etc.
Deterioration
46
What are the methods in Identification Test (ID)
Chemical Method and Instrumental method
47
It is a method under ID test where there is change in color precipitation and evolution of gas
Chemical method
48
It is a method under ID tests where there is IR spec, UV-vis speC, HPLC, and nuclear magnetic resonance
Instrumental method
49
Vibration, compared to standard
IR spec
50
Excitation: absorbed and transmitted light
UV-vis speC
51
Retention factor
HPLC
52
HPLC meaning
High Performance Liquid Chromatography
53
Amount of magnetic signal or field
Nuclear magnetic resonance
54
TEST FOR PURITY includes:
Monograph Assay
55
Includes titration and Instrument method (GC & HPLC)
Monograph Assay
56
GC meaning
Gas chromatography
57
LIMIT TEST includes:
Gross, Biological and Chemical Impurities
58
Insoluble matter and dirt
Gross Impurities
59
o Microorganism (natural products) o Cell debris o Degredation products
Biological Impurities
60
Trace metals
Chemical Impurities
61
AgNO3 -> AgCl
Chloride
62
BaCL2 -> BaSO4
Sulphates
63
Diethyldithiocarbamate (vis-spec 535-45 mm)
Arsenic
64
Flame spectroscopy
Sodium and Calcium
65
Ammonium thocyanate -> blood red complex
Iron
66
H2S -> black
Heavy Metals
67
Under chemical impurities what are the exceptions elements?
* Zinc – white (znow) * Cadnium – yellow (yellow cad) * Tin – Orange (can) * Mn – pink (man wear ink)
68
PHYSICAL TESTS INCLUDES 6:
Specific Gravity, Solubility Test, Refractive Index, Optical activity, Melting Point, and Boiling Point
69
Ratio of the wt of the sample or wt of standard water
Specific gravity
70
Includes Pyconometer and Westphal Balance
Specific Gravity
71
Dissolution of the compound in a suitable solvent
Solubility Test
72
Under Refractive Index is ___
Abbe refractometer
73
Bending of light and ratio of the velocity of light in air and velocity of light in a sample
Abbe refractometer
74
Under optical activity is ____
Polarimeter
75
Measures the angle of optical rotation of a plane polarized light in passing thru a sample material
Polarimeter
76
The temperature at which the vapor pressure of a liquid is equal to the atmospheric pressure.
Boiling Point

Pharm Analysis 2 (1 decks)

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